Pharmaceutical Processing - July 2008 - cResults - (Page 4) 4 p h a r m p r o. c o m Operational Excellence Hrs. Distribution By Owner Owner OMER BOAZ RMASLATON EYLEM Avail Hrs. 30.75 30 220 266.6 Unvail. Hrs. 1.25 2 13 26.4 % Efficiency 35.45 19.87 75.08 99.06 Figure 5: Unavailable Hours by QA Tech. The table outlines by user name the available hours for the period selected, the unavailable hours and the percent efficiency gained via the ratio of earned hours vs. available hours. Figure 6: Batch Record Errors by Type ment for correction with the visibility of when the batch record was reviewed, what were the errors/clarifications, what are the categories, which areas these errors are associated with as it is tracked throughout the system. This has improved response time for corrections by almost 20%. Figures 4, 5 and 6, outline some of the information that became available to the project team. The unavailable hours by QA tech (Figure 5) help the management team to assess the overall activities performed by QA tech beyond the direct tasks in order to further enhance the effectiveness of the QA team by streamlining meeting structure and frequency and providing more training if shown as below the corporate guidance. The pie chart (Figure 6) is used to identify the errors made on the batch records and provide the team with the ability to analyze the root cause and prioritize the effort to improve the right first time documentation. Other valuable information includes cycle time by QA and cycle time to correct errors by manufacturing and packaging. Other charts that are used routinely are right first time by area and efficiency by QA techs. The top of figure 5 provides the team with all the efficiency losses related to activities such as training, breaks, meetings etc., while other charts show where the QA tech time is spent. The QA efficiency calculation in Figure 5 is done by establishing standards for QA activities and measuring the earned hours during the shift based on activities completed vs. the overall hours in a given shift as follow: • Earned Hours = Σ All Activities Performed *Standard time to perform these activities • Available Hours = Available direct staffing hrs – Σ All the planned unavailable activities (i.e., meetings, training) QA Efficiency = (Earned Hours/Available Hours) * 100% The project team is able to review all the activities and their value added contribution by comparing actual vs. standards, and in the process of changing frequencies, the content of the QA activities to reduce the non-value added activities performed by the QA techs. At the end of this journey, cME provides a continuous improvement infrastructure to improve the value added compliance by the QA team. The key paradigm shift is the view of QA as a production entity that produces reports, batch records, and audits, so that metrics may be established for each of these activities. The key items for efficiency management that were established as the root causes and the building blocks for efficiency improvement during this journey were: * Improve visibility and provide real-time Key Performance Indicators to detect trends and potential issues. * Increase ownership and accountability. * Provide accurate and factual quantification for all QA activities by process mapping, identifying the value added vs. non-value added. * Have clear expectations, and standards for each of the QA activities to ensure ample time is being spent where needed. * Establish a continuous improvements platform. The above key root causes were identified and targeted by the QA improvement team and some of the key achievements of the 3 months of implementation were: * Errors in batch records documentation were reduced in the month of August by 29.7% compared with the month of June. * Response time of Manufacturing to correct errors was reduced by 18.7%. * Reviewer efficiency is up more than 10% based on earned hours vs. available hours. * Par is also challenging many traditional pharmpro.com
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